Even the head of $6M liver study doesn’t know what’s going on at San Diego VA

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So we went straight to the top in our ongoing investigation of the San Diego VA — to Dr. Ramon Bataller. He’s leading a huge, international project looking into alcoholic liver disease, and the San Diego VA has been collecting samples from sick veterans and sending them to his storage facility as part of that study.

An inewsource investigation has uncovered that researchers at the San Diego VA were involved in taking liver samples from sick veterans without their permission, a serious ethical lapse.

inewsource is continuing to report on the poor oversight of this dangerous human research and the lack of accountability so far for those responsible.

The problem, as we’ve reported, is that the patients in San Diego weren’t told the study could compromise their health even further, an ethical violation that an internal review called “serious noncompliance” and has sparked a call for a congressional hearing.

So far, our investigation has led us to contradictory government reports, confusing timelines and disagreements on basic facts. We hoped talking to Bataller would give us the answers we’ve been looking for: How did these violations occur and what’s being done about them?

But Bataller, who said he’s been in “constant communication” with the San Diego VA and the National Institutes of Health about the study’s flaws, left us more confused than when we started.

The San Diego VA hasn’t helped us, either — not responding since March 1 to more than a dozen emails and phone calls about Bataller’s claims.

Our goal with this story isn’t to leave you confused. It’s to bring you along in our reporting process as we try to unravel a complicated story that directly affects the health of veterans in San Diego County.

Confusing statements

With a friendly demeanor and thick Spanish accent, he spoke to us for an hour by phone about his ambitious project: building the largest collection of liver samples from patients with alcoholic liver disease so doctors can develop new treatments.

He should know more about it than anyone — he’s ultimately responsible for the $6 million federally funded research that involves collecting those samples, including from patients at the San Diego VA, and then analyzing them.

Yet the interview with Bataller was perplexing. He told us the lead doctor at the VA was banned, but didn’t elaborate; he said all the data from San Diego weren’t used in any research articles, but he didn’t answer questions about how that was possible; he said the San Diego study was “closed” but that doesn’t match up with VA documentation; and he later blamed his “language barrier” for saying he would “think twice” about working with a VA doctor involved in the project.

Let’s start with his first statement: Because of the violations, “all of the data from San Diego has been banished from any study that (we can) publish,” Bataller told us.

He said that or variations of it three times in the interview and again in an email. None of the San Diego VA samples were ever used in any published research articles, he said, because they were not collected properly and that could affect his reputation.

The San Diego VA, shown on Nov. 15, 2018, provides services to the nearly quarter-million veterans in San Diego and Imperial counties, and has one of the largest research programs in the national VA network. (Megan Wood/inewsource)

“I don’t want to retract any paper after years of work,” Bataller said.

But he couldn’t explain how that was possible: Between the time when VA doctors began sending samples to his collection and when Bataller became aware of the violations, a number of research papers based on the samples were published. No one, including Bataller, has been able to tell us why the San Diego tissue samples wouldn’t have been used during that time.

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He said the San Diego VA’s role in the study was “closed months ago” after he learned about violations there involving the liver research. It’s true that VA doctors aren’t collecting human samples anymore, but a Jan. 14 letter from the VA said the study isn’t technically closed: It “will remain on hold” until the VA “reviews and approves a closure application.”

The National Institutes of Health, which funded the project, wouldn’t clarify things for us either. A spokeswoman said the NIH doesn’t “discuss specific actions or details of the decision-making process on specific grant awards.”

Bataller followed up by saying Ho, his lead physician at the San Diego VA, was “banned” from future research, but he didn’t elaborate.

“The local people in San Diego have been in constant communication, talking to me about the consequences of the study, to ban Dr. Ho,” he said.

That’s the first mention in interviews or investigative reports of the former chief of gastroenterology at the San Diego VA being banned. Official reports have said Ho, who also was a professor of medicine at the University of California San Diego, retired last year to take a job in Dubai.

We’ve emailed Ho multiple times since November, but he hasn’t agreed to speak with us.

Backtracking about Dr. Schnabl

In his interview, Bataller told us repeatedly about the importance of his larger research project. He acknowledged mistakes were made and said he worries the “local irregularities” at the San Diego VA may jeopardize helpful research in the future.

What occurred at the VA, he said, “is a local thing that happened in one center, in a low-risk observational study in a center that has one of the best researchers. Dr. Bernd Schnabl is one of the best in the world.”

Schnabl is a staff physician at the VA and a professor of medicine at UCSD. He’s involved in this project in several ways, so we built a graphic to show you:

First, Schnabl is leading one of three research projects that draws from Bataller’s repository. Schnabl’s partner for that project is UCSD Vice Chancellor for Health Sciences David Brenner, who runs the university’s medical school. They’re examining the bacteria in the guts of patients with alcoholic liver disease.

Second, Schnabl and Brenner are on Bataller’s steering committee, which oversees interactions among the sites and distributes samples from the repository to researchers.

Third, Schnabl was listed in VA documents as responsible for identifying patients to join the research and obtaining their consent to participate. (Bataller told us he was unaware Schnabl was signing up patients for the study.)

Schnabl took over Ho’s role as the San Diego VA’s lead researcher on the project last June.

We asked Bataller if he would ever work with Ho again.

“No way,” Bataller said. “A person who is not precise in everything? No way.”

Then we asked Bataller if he would work with Schnabl again.

“I will think twice about that,” Bataller said. “Because I want people very careful in all these matters, as you can imagine.”

We reached out to Schnabl to hear what he had to say about Bataller’s comments. Schnabl said media requests must go through a VA spokesperson.

Then San Diego VA spokeswoman Cynthia Butler emailed us.

“We have reached out to Dr. Bateller(sic) and he has stated that he did not make the statements that you have attributed to him,” she wrote. “In fact, Dr. Bateller(sic) and Dr. Schnabl are continuing to collaborate and both are serving on a steering committee for the National Institutes of Health that is intended to continue to improve our understanding of alcoholic hepatitis.

“Given this major discrepancy, you may want to reevaluate the premise of your piece.”

We recorded our interview with Bataller with his permission. He not only said that statement, he repeated the question back to us before answering it.

We sent Butler and another VA spokesperson a copy of that recording. Since then, they have stopped responding to follow-up questions sent over email and voicemail.

We also asked Bataller to clarify. In response, we got an email from a spokeswoman at the University of Pittsburgh, where Bataller works at the department of medicine.

She emailed a statement on behalf of Bataller: “With the language barrier, I may have misinterpreted your question during our phone conversation. I hold high regard for Dr. Schnabl. I continue to collaborate with him and look forward to future projects.”

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About Brad Racino:

Brad Racino is a senior investigative reporter and assistant director at inewsource. To contact him with tips, suggestions or corrections, please email bradracino [at] inewsource [dot] org. You can contact him securely on Signal (845-553-4170).